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This document provides guidance to investigators regarding the use of protected health information (PHI) in research without subject authorization, detailing the conditions under which such use is
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How to fill out SOP: UTHSC IRB Guidance on Use of PHI Without Subject Authorization

01
Review the UTHSC IRB guidelines thoroughly to understand the requirements for using PHI without subject authorization.
02
Gather all relevant documentation regarding the project that necessitates the use of PHI.
03
Clearly define the purpose of using PHI without authorization and ensure it aligns with IRB stipulations.
04
Identify any identifiable information that will be used and how it will be safeguarded.
05
Prepare a rationale for why subject authorization cannot be obtained, providing justifications as required by the IRB.
06
Complete the SOP forms with precise, clear, and comprehensive information based on the project's specifics.
07
Submit the completed SOP to the UTHSC IRB for review along with any required supporting documents.
08
Respond to any queries or requests for additional information from the IRB in a timely manner.

Who needs SOP: UTHSC IRB Guidance on Use of PHI Without Subject Authorization?

01
Researchers conducting studies that involve the use of PHI without subject authorization.
02
Institutional Review Board (IRB) members needing to assess proposals involving PHI.
03
Compliance officers and staff responsible for ensuring that research protocols align with ethical guidelines and regulations.
04
Administrative staff involved in managing IRB applications and documentation.
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SOP: UTHSC IRB Guidance on Use of PHI Without Subject Authorization outlines the procedures and regulations governing the use of protected health information (PHI) in research without obtaining authorization from subjects, ensuring compliance with applicable privacy laws.
Researchers, faculty, and staff involved in studies utilizing PHI without subject authorization must file SOP: UTHSC IRB Guidance on Use of PHI Without Subject Authorization to ensure their work adheres to ethical and legal standards.
To fill out the SOP, individuals should provide detailed information about the research project, including the rationale for using PHI without authorization, the specific types of PHI being used, and how the data will be safeguarded to protect subjects' privacy.
The purpose of the SOP is to establish clear guidelines for the ethical use of PHI in research settings where subject authorization is not feasible, ensuring that researchers maintain compliance with federal regulations while respecting individual privacy.
The information that must be reported includes the justification for the use of PHI without authorization, the categories of PHI involved, the identity of the data holders, and the measures taken to minimize risks to individuals' privacy.
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